Last updated on 22 Feb 2021

Human tissue xenografts

The purpose of this guidance is to set out our policy on human tissue xenografts, whether they are relevant material that fall under the licensing framework of the HT Act 2004 and the consent implications.

Xenografts are cells, tissue or organs that are transplanted from one species to another. Human tissue xenografts being the transplantation of human tissue into another species. Human tissue xenografts are widely used in research in connection with disorders, or the functioning, of the human body. We have received enquiries regarding their use and the requirements of the HT Act 2004.

Relevant material

Human tissue xenografts are classed as ‘relevant material’ as they will contain cells that have come from human bodies.

Licensing requirements under the HT Act 2004

The application of  human tissue xenografts is not considered a method of storing human tissue or cells and therefore does not require a storage licence. The human tissue will be integrated and become a part of the recipient species. However, where human tissues and cells are being stored for a scheduled purpose, such as ‘research in connection with disorders, or the functioning, of the human body’ before they are transplanted into a recipient species, a storage licence may be required.